Closed-Loop Therapeutic Refinement Using Local Field Potentials in Parkinson's Disease

Summary

This multi-center pilot study compares conventional DBS (cDBS) and adaptive DBS (aDBS) in Parkinson's disease patients using the Medtronic Percept™ system.

The aim of the study is to identify which patients benefit most from aDBS, and to explore patient and LFP signal characteristics as well as stimulation parameters as potential predictors of treatment preference and efficacy. The study utilizes a blinded, randomized N-of-1 trial design, where each patient tests the following:

* Original cDBS settings (cDBS);
* Optimized cDBS settings (O-cDBS);
* Optimized aDBS settings (O-aDBS) Each setting is evaluated for a minimum of 2 and maximum of 7 days at home in a randomized order (patient blinded).

The main study outcome consists of the patient's final preference among the three DBS programs: original cDBS, O-cDBS, or O-aDBS. Secondary outcomes focus on differences between cDBS, O-cDBS and O-aDBS regarding the following parameters (among others):

* Quality of life (PDQ-39);
* Patient satisfaction (5-point Likert Scale);
* (Non)-motor fluctuations (MDS-UPDRS-III + MDS-NMS-Q);
* Time spent in "ON"/"OFF" motor phases (symptom diary + MDS-UPDRS IV);
* Time spent experiencing dyskinesia (symptom diary + MDS-UPDRS IV);
* Time spent with the most bothersome symptom (symptom diary + MDSUPDRS IV);
* Stimulation parameters;
* Local field potentials.

The study also incorporates real-world home-based assessments using the Experience Sampling Method (ESM) to capture motor and non-motor symptom fluctuations in daily life and identify differences among the three settings.

Conditions

• Parkinson's Disease (PD)

Interventions

DEVICE

Conventional DBS

Treatment for a minimum of 2 to a maximum of 7 days with the patient's original conventional DBS (cDBS) settings.

DEVICE

Optimized conventional DBS

Treatment for a minimum of 2 to a maximum of 7 days with a previously optimized version of the patient's original conventional DBS (O-cDBS) settings.

DEVICE

Optimized adaptive DBS

Treatment for a minimum of 2 to a maximum of 7 days with previously optimized adaptive DBS (O-aDBS) settings.

Sponsors & Collaborators

• Maastricht University Medical Center

  collaborator OTHER

• Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

  collaborator OTHER

• HagaZiekenhuis

  lead OTHER

Principal Investigators

• Maria Fiorella Contarino, MD, PhD · HagaZiekenhuis

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2027-06-01

Completion

2027-06-01

Countries

• Netherlands

Study Locations